Posted by Michael Wonder on 01 Oct 2019
US Food and Drug Administration review of statistical analysis of patient-reported outcomes in lung cancer clinical trials approved between January, 2008, and December, 2017
1 October 2019 - With the advent of patient-focused drug development, the US FDA has redoubled its efforts to review patient-reported outcome data in cancer trials submitted as part of a drug's marketing application.
This Review aims to characterise the statistical analysis of PRO data from pivotal lung cancer trials submitted to support FDA drug approval between January 2008, and December 2017.
For each trial and PRO instrument identified, we evaluated pre-specified PRO concepts, statistical analysis, missing data and sensitivity analysis, instrument completion, and clinical relevance.
Of the 37 pivotal lung cancer trials used to support FDA drug approval, 25 (68%) trials included PRO measures.
